Pullback Pressure Gradient (PPG) Global Registry

Last updated: October 9, 2024
Sponsor: VZW Cardiovascular Research Center Aalst
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Angina

Congestive Heart Failure

Myocardial Ischemia

Treatment

N/A

Clinical Study ID

NCT04789317
CRI050
  • Ages 18-100
  • All Genders

Study Summary

The purpose of this study is to determine the predictive capacity of the Pullback Pressure Gradient (PPG) index for post-PCI FFR and to determine the impact of the PPG index on clinical decision making about revascularization and on clinical outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Consecutive patients with stable coronary artery disease or stabilized acutecoronary syndrome and invasive FFR measurement ≤0.80.

Exclusion

Exclusion Criteria:

  • Angiographic exclusion criteria
  1. Ostial lesions.

  2. Severe vessel tortuosity.

  3. Vessel rewiring deemed 'difficult' by the operator.

  4. Bifurcation with planned two-stent strategy.

  5. NSTEMI culprit vessel.

  6. STEMI

  7. Uncontrolled or recurrent ventricular tachycardia.

  8. Hemodynamic instability

  9. Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2

Study Design

Total Participants: 982
Study Start date:
December 23, 2020
Estimated Completion Date:
December 31, 2026

Study Description

A Fractional Flow Reserve (FFR) evaluation comprises measurement of a distal single value and a pullback maneuver during hyperemic conditions. The PPGindex is a novel metric derived from the FFR pullback curve.3 This metric complements the distal FFR value by informing the spatial distribution of epicardial resistance (i.e. focal or diffuse) along the coronary vessel. The PPGindex relies on two components: first, the magnitude of pressure drop determined as a maximal pressure gradient over 20 millimeters relative to the total vessel gradient; and second, the length of functional disease relative to total vessel length. These two parameters are weighted equally to provide a metric that ranges from 0 to 1. PPGindex values approaching 1 represent functional focal coronary artery disease (CAD) whereas values close to 0 represent diffuse functional CAD. Until now, the interpretation of the FFR pullback relied on visual assessment. The PPGindex quantifies the pattern of functional CAD and has been shown to predict functionally complete revascularization. Percutaneous revascularization in vessels with high PPGindex is associated with high post-PCI FFR and vast improvement in epicardial conductance whilst PCI in vessels with low PPGindex results in low post-PCI FFR. An curvilinear relationship is observed between PPGindex and functional gain (i.e. FFR post-PCI minus FFR pre-PCI). The PPGindex, therefore, aims to predict the response to PCI in physiological terms.

Calculation of the PPGindex is indicated in cases with an FFR≤0.80. FFR pullbacks are performed under hyperemic conditions at a steady pace during manual pullback. A calculation of the PPGindex using the Coroflow console (Coroventis Research Ab, Uppsala, Sweden) is available for online use and computes the PPG value immediately after the pullback maneuver. This software also includes an automated drift correction. The pullback curve is depicted on an dedicated pullback display screen and the pressure gradients are shown per millimeter, allowing correlation between the location of pressure step-ups and the anatomical target for PCI. In summary, we can distinguish three points where FFR influences the clinical decision-making process. First, an FFR ≤0.80 indicates potential benefit of revascularization. Second, the pullback curve assesses disease pattern and PPG index value quantifies it, helping de physician in the decision about treatment options (e.g. PCI, CABG or OMT). And, third, the location of pressure step-ups along the vessels helps plan the PCI strategy with respect to coverage of functional disease. A combined FFR and PPG-guided PCI strategy has the potential to improve patient selection and enhance procedural planning.

The purpose of this study is to determine the predictive capacity of the PPG index for post-PCI FFR and to determine the impact of the PPG index on clinical decision making about revascularization and on clinical outcomes.

Connect with a study center

  • Monash Medical Center

    Melbourne,
    Australia

    Site Not Available

  • Concord Repatriation General Hospital

    Sydney,
    Australia

    Site Not Available

  • OLV-Aalst

    Aalst, Oost-Vlaanderen 9300
    Belgium

    Active - Recruiting

  • OLV Aalst

    Aalst,
    Belgium

    Site Not Available

  • Aalborg University Hospital

    Aalborg,
    Denmark

    Site Not Available

  • Aarhus University Hospital

    Aarhus,
    Denmark

    Site Not Available

  • Righospitalet

    Copenhagen,
    Denmark

    Site Not Available

  • Institut Arnault Tzanck

    Nice,
    France

    Site Not Available

  • Ferrara University

    Ferrara,
    Italy

    Site Not Available

  • Centro Cardiologico Monzino

    Milan, 20138
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome,
    Italy

    Site Not Available

  • Showa University Hospital

    Shinagawa, Tokyo 1420064
    Japan

    Site Not Available

  • Aichi University

    Aichi,
    Japan

    Site Not Available

  • Gifu Heart Center

    Gifu,
    Japan

    Site Not Available

  • Showa University Hospital

    Tokyo,
    Japan

    Site Not Available

  • Tokyo D Tower Hospital

    Tokyo,
    Japan

    Site Not Available

  • Catharina Ziekenhuis

    Eindhoven,
    Netherlands

    Site Not Available

  • Radboud UMC

    Nijmegen,
    Netherlands

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario de La Princesa

    Madrid,
    Spain

    Site Not Available

  • Karolinska Institutet

    Stockholm,
    Sweden

    Site Not Available

  • CHUV

    Lausanne,
    Switzerland

    Site Not Available

  • University of Glasgow

    Glasgow, G12 8QQ
    United Kingdom

    Site Not Available

  • Guy and St Thomas NHS Foundation Trust

    London,
    United Kingdom

    Site Not Available

  • King's College London

    London, WC2R 2LS
    United Kingdom

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • St Francis Hospital and Heart Center

    New York, New York 11576
    United States

    Site Not Available

  • Memorial Hermann Texas Medical Center

    Texas City, Texas 77030
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.